Gliederung

Introduction

Access to information about ongoing, completed and published clinical research is essential for appropriate decision-making. Researchers, research funders, policy-makers, medical practitioners, patients and the general public need such information – to help guide research or make treatment decisions.

Methods

The World Health Organization, based on a consensus developed by a broad variety of stakeholders, is establishing an international clinical trial registration platform. This platform will link registers into a comprehensive network, harmonize register and trial registration standards, provide global trial identification and search capability, promote compliance, and help strengthen research monitoring capacity where needed. WHO will undertake this effort with the advice and assistance of a full array of clinical research stakeholders.

A technical consultation in April 2005 resulted in consensus on which trials to register and what data from each trial should be registered. There was also broad agreement on where trials should be registered and when and how results should be disclosed.

WHO Secretariat is working with national governments and national and international science and research bodies to resolve outstanding standard-related issues. Concurrently, the network solution to link registers that meet certain criteria and identify those trials with an international unique identifier is being developed.

Results and Discussion

Trial registration is a complex process with technological, scientific, ethical and legal aspects. An international consensus building strategy supported by national governments is crucial. There has been some progress in the past 12 months in terms of public understanding and bringing together different stakeholders. However, more work needs to be done to resolve ongoing disagreements and implement an international platform.